Sleeve for bone fixation device

ABSTRACT

Disclosed is a bone fixation device of the type useful for connecting two or more bones or bone fragments together or connecting soft tissue or tendon to bone. The device comprises an elongate body having a distal anchor thereon. An axially moveable proximal anchor is carried by the proximal end of the fixation device, to accommodate different bone dimensions and permit appropriate tensioning of the fixation device. A sleeve can surround at least a portion of the bone fixation device to promote bone in-growth with or at the bone joint or fracture to facilitate fusion of the bone segment .

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 13/424,174, filed Mar. 19, 2012, which claims a prioritybenefit to U.S. Provisional Application No. 61/454,833, filed Mar. 21,2011, the disclosures of both of which are hereby incorporated byreference as if set forth in their entirety herein.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to medical devices, and, moreparticularly, to bone fixation devices.

Description of the Related Art

Bones which have been fractured, either by accident or severed bysurgical procedure, must be kept together for lengthy periods of time inorder to permit the recalcification and bonding of the severed parts.Accordingly, adjoining parts of a severed or fractured bone aretypically clamped together or attached to one another by means of a pinor a screw driven through the rejoined parts. Movement of the pertinentpart of the body can then be kept at a minimum, such as by applicationof a cast, brace, splint, or other conventional technique, in order topromote healing and avoid mechanical stresses that can cause the boneparts to separate during bodily activity.

The surgical procedure of attaching two or more parts of a bone with apin-like device requires an incision into the tissue surrounding thebone and the drilling of a hole through the bone parts to be joined. Dueto the significant variation in bone size, configuration, and loadrequirements, a wide variety of bone fixation devices have beendeveloped in the prior art. In general, the current standard of carerelies upon a variety of metal wires, screws, and clamps to stabilizethe bone fragments during the healing process. Following a sufficientbone healing period of time, the percutaneous access site or other sitecan require re-opening to permit removal of the bone fixation device.

Furthermore, a variety of methods have been developed to treat displacedor fractured vertebra and to fix them within the vertebral column. Suchmethods typically include various fixation systems that are used for thestabilization of fractures and/or fusions of various portions of thespine. These fixation systems may include a variety of longitudinalelements such as rods or plates which span two or more vertebra and areaffixed to the vertebra by various fixation elements such as wires,staples, and screws (often inserted through the pedicles of thevertebra). These systems may be affixed to either the posterior or theanterior side of the spine. In other applications, one or more bonescrews may be inserted through adjacent vertebrae to providestabilization.

The internal fixation techniques commonly followed today frequently relyupon the use of screws, plates, Kirschner wires (K-wires),intramedullary pins, wiring and combinations of the foregoing. Theparticular device or combination of devices is selected to achieve thebest anatomic and functional condition of the traumatized bone with thesimplest operative procedure and with a minimal use of foreign-implantedstabilizing material. A variety of alternate bone fixation devices arealso known in the art, such as, for example, those disclosed in U.S.Pat. No. 4,688,561 to Reese, U.S. Pat. No. 4,790,304 to Rosenberg, andU.S. Pat. No. 5,370,646 to Reese, et al.

A variety of elongated implants (nail, screw, pin, etc.) have beendeveloped, which are adapted to be positioned along the longitudinalaxis of the femoral neck with a leading distal end portion in thefemoral head so as to stabilize a fracture of the femoral neck. Theelongated implant can be implanted by itself or connected to anotherimplant such as a side plate or intramedullary rod. The leading endportion of the implant typically includes means to positively grip thefemoral head bone (external threads, expanding arms, etc.), but theinclusion of such gripping means can introduce several significantproblems. First, implants with sharp edges on the leading end portion,such as the externally threaded implants, exhibit a tendency to migrateproximally towards the hip joint bearing surface after implantation.This can occur when the proximal cortical bone has insufficientintegrity to resist distal movement of the screw head. Such proximalmigration under physiological loading, which is also referred to asfemoral head cut-out, can lead to significant damage to the adjacent hipjoint. Also, the externally threaded implants can generate large stressconcentrations in the bone during implantation which can lead tostripping of the threads formed in the bone and thus a weakened grip.The movable arms of known expanding arm devices are usually free at oneend and attached at the other end to the main body of the leading endportion of the implant. As a result, all fatigue loading is concentratedat the attached ends of the arms and undesirably large bending momentsare realized at the points of attachment. In addition, conventionalthreaded implants generally exhibit insufficient holding power undertension, such that the threads can be stripped out of the femoral headeither by overtightening during the implantation procedure or duringpost operative loading by the patient's weight.

Bone fasteners can also be used for the stabilization of fracturesand/or fusion of various portions of the spine. Such fasteners are ofteninserted through the pedicles of the vertebra and can be used incombination with a variety of longitudinal elements such as rods orplates which span two or more vertebra. These systems can be affixed toeither the posterior or the anterior side of the spine.

Notwithstanding the variety of bone fasteners that have been developedin the prior art, there remains a need for a bone fixation device thateffectively integrates with the bone to secure a fracture, secure softtissue or tendon to the bone and/or provide stability between bones(e.g., vertebrae).

SUMMARY OF THE INVENTION

There is provided in accordance with some embodiments of the presentinvention, a fixation device for securing a first bone fragment to asecond bone fragment or a first bone to a second bone. Alternatively,the fixation device can be used to secure soft tissue to a bone. Thefixation device can comprise a sleeve disposed around the outer surfacethat promotes integration of the fixation device with bone material.

In some embodiments, an orthopedic fixation device comprises an elongatebody having a proximal end with a proximal anchor and a distal end witha distal anchor. A sleeve covers at least a portion of the fixationdevice. The sleeve comprises a material configured promote fusion withina joint or fracture.

One embodiment comprises a sleeve for use with an orthopedic fixationdevice. The sleeve comprising a tubular body with an inner diameter thatis generally the same as the outer diameter of the fixation device. Thesleeve is configured to promote fusion across a bone fracture or joint.

Another embodiment comprises a method of providing bone fixation. Themethod can include advancing a fixation device that comprises a bodyhaving a first portion that forms a bone anchor and a second portionthat forms a proximal end into a first structure of a bone structure,securing the first structure to a second structure by advancing aproximal anchor against the second structure; and placing a sleeveformed substantially of allograft and carried by the fixation deviceacross a juncture between the first structure and the second structure.

Another embodiment comprises a method of providing bone fixation. Themethod can include forming a hole extending across a juncture betweenthe first structure and the second structure fixation and advancing asleeve formed substantially of bone allograft into the hole such thatthe sleeve spans the juncture between the first structure and the secondstructure.

Further features and advantages of the present application will becomeapparent to those of skill in the art in view of the detaileddescription of preferred embodiments which follows, when consideredtogether with the attached claims and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a posterior elevational view of a portion of a vertebra havingan embodiment of a fixation device implanted therein.

FIG. 2A is a side perspective view of a fixation device similar to thatof FIG. 1.

FIG. 2B is a side elevational view of the fixation device of FIG. 2A.

FIG. 2C is a cross-sectional view taken through line 4-4 of FIG. 2B.

FIG. 2D is an enlarged view of portion 2D of FIG. 2C.

FIG. 3A is an enlarged view of portion 3A of FIG. 2C with the fixationdevice in a first position.

FIG. 3B is an enlarged view of portion 3B of FIG. 2C with the fixationdevice in a second position.

FIG. 4 is a cross-sectional view taken through line 4-4 of FIG. 2B.

FIGS. 5A-F are perspective, side, top, bottom and cross-sectional viewsof an embodiment of a proximal anchor.

FIG. 6A is a perspective view of another embodiment of a proximalanchor.

FIGS. 6B and 6C are enlarged views of a portion of an embodiment of aproximal anchor.

FIG. 6D is a front view of the proximal anchor of FIG. 6A.

FIG. 7A is a perspective view of a washer and a fixation device.

FIG. 7B is a partial cross-sectional side view of the washer of FIG. 7Aand a housing of a proximal anchor.

FIG. 7C is a bottom view of the washer of FIG. 7A.

FIG. 8 is a side elevational view of a double helix distal anchor.

FIG. 9A is a perspective view of an embodiment of a proximal anchor withan embodiment of a sleeve.

FIGS. 9B-9E are perspective views of several embodiments of sleeveshaving surface features.

FIG. 10A is a perspective view of an embodiment of a fixation devicewith another embodiment of a sleeve.

FIG. 10B is a perspective front view of the fixation device of FIG. 10Awith an embodiment of a sleeve.

FIG. 11 is a perspective view of another embodiment of a proximal anchorwith another embodiment of a sleeve.

FIG. 12 is a posterior view of a portion of the lumbar spine with anembodiment of a fixation device used as a trans-facet screw.

FIG. 13 is a posterior view of a portion of the lumbar spine with anembodiment of a fixation device used as a trans-facet screw.

FIG. 14 is a posterior view of a portion of the lumbar spine with anembodiment of a fixation device used as a trans-facet screw.

FIG. 15 is an anterior view of the distal tibia and fibula, withfixation devices across lateral and medial malleolar fractures.

FIG. 16 illustrate a procedure for using an embodiment of a fixationdevice to secure a femoral neck fracture.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

As will be described below, in certain embodiments, sleeves or similarstructures that fit over the collar or shaft of a fixation device can soas to cross a bone joint or fracture site to promote bone in-growth andfusion within the bone joint or at the fracture site . The sleeves canbe made of a biocompatible material, such as allograft (e.g., corticalbone, cancellous bone, demineralized bone matrix (DBM) or bonemorphogenic protein (BMP)), that promotes bone in-growth and fusionwithin and/or across the joint (or facture). The embodiments of fixationdevices described herein will be disclosed primarily in the context of aspinal fixation procedure and fusion across a facet joint. However, themethods and structures disclosed herein are intended for application inany of a variety medical applications, as will be apparent to those ofskill in the art in view of the disclosure herein.

As noted above, the bone fixation devices described herein can be usedin a variety of techniques to stabilize the spine. For example, the bonefixation devices can be used as pedicle or facet screws that can beunilaterally or bilaterally symmetrically mounted on adjacent ornon-adjacent vertebrae and used in combination one or more linkage rodsor plates to facilitate fusion across the facet joint and between one ormore vertebrae. The bone fixation devices disclosed herein can also beused as a fixation screw to secure two adjacent vertebra to each otherin a trans-laminar, trans-facet or facet-pedicle (e.g., the Bouchertechnique) applications. One of skill of the art will also recognizethat the bone fixation devices disclosed herein can be used forposterior stability after laminectomy, artificial disc replacement,repairing odontoid fractures and other fractures of the spine, and otherapplications for providing temporary or permanent stability in thespinal column.

In other embodiments, the bone fixation devices can be in a wide varietyof fractures and such as, for example, osteotomies in the hand, foot,and tarsal bones such as the calcaneus and talus. In other embodiments,fibular and tibial malleoli, pilon fractures and other fractures of thebones of the leg can be fixated and stabilized with one or more of theembodiments described herein. In yet other embodiments, the fixationdevice can also be used in the context of fractures of the proximalfemur.

Referring to FIG. 1, there is illustrated a side elevational view of anembodiment of a bone fixation device 12 positioned within adjacentvertabrae 10. As will be explained in more detail below, the fixationdevice 12 may be used in a variety of techniques to stabilize the spine.For example, in the illustrated embodiment, the fixation devices 12 canbe used as pedicle or facet screws that may be unilaterally orbilaterally symmetrically mounted on adjacent or non-adjacent vertebraeand used in combination one or more linkage rods or plates to facilitatefusion of one or more vertebrae. The fixation devices 12 disclosedherein may also be used as a fixation screw to secure two adjacentvertebra to each other in a trans-laminar, trans-facet or facet-pedicle(e.g., the Boucher technique) applications. One of skill of the art willalso recognize that the bone fixation devices disclosed herein may beused for posterior stability after laminectomy, artificial discreplacement, repairing odontoid fractures and other fractures of thespine, and other applications for providing temporary or permanentstability in the spinal column. Fixation Device

FIGS. 2A-D illustrate an embodiment of a fixation device 212 having abody 228 and a proximal anchor 600. In the illustrated embodiment, thebody 228 comprises a first portion 236 and a second portion 238 that arecoupled together at a junction 240 (FIG. 2D). The first portion 236 cancarry the distal anchor 234 while the second portion 238 forms theproximal end 230 of the body 228. The first and second portions 236, 238are preferably detachably coupled to each other at the junction 240. Inthe illustrated embodiment, the first and second portions 236, 238 aredetachably coupled to each other via interlocking threads. Specifically,as best seen in FIG. 2D, the body 228 can include an inner surface 241,which defines a central lumen 242 that preferably extends from theproximal end 230 to the distal end 232 throughout the body 228. At theproximal end of the first portion 236, the inner surface 241 can includea first threaded portion 244. The first threaded portion 244 can beconfigured to mate with a second threaded portion 246, which is locatedon the outer surface 245 of the second portion 238. The interlockingannular threads of the first and second threaded portions 244, 246 canenable the first and second portions 236, 238 to be detachably coupledto each other. In some embodiments, the orientation of the first andsecond threaded portions 244, 246 can be reversed. That is, the firstthreaded portion 244 can be located on the outer surface of the firstportion 236 and the second threaded portion 246 can be located on theinner surface 241 at the distal end of the second portion 238. Any of avariety of other releasable complementary engagement structures can alsobe used, to allow removal of second portion 238 following implantation,as is discussed below.

The second portion 238 can comprise any of a variety of tensioningelements for permitting proximal tension to be placed on the distalanchor 234 while the proximal anchor 600 is advanced distally tocompress the fracture. For example, any of a variety of tubes or wirescan be removably attached to the first portion 236 and extend proximallyto the proximal handpiece. In one such arrangement, the first portion236 can include a releasable connector in the form of a latchingelement, such as an eye or hook. The second portion 238 can include acomplementary releasable connector (e.g., a complementary hook or eye)for engaging the first portion 236. In this manner, the second portion238 can be detachably coupled to the first portion 236 such thatproximal traction can be applied to the first portion 236 through thesecond portion, as will be explained below. Alternatively, the secondportion 238 can be provided with an eye or hook, or transverse bar,around which or through which a suture or wire can be advanced, bothends of which are retained at the proximal end of the device. Followingproximal tension on the tensioning element during the compression step,one end of the suture or wire is released, and the other end can bepulled free of the device. Alternate releasable proximal tensioningstructures can be devised by those of skill in the art in view of thedisclosure herein.

With continued reference to FIG. 2A, the proximal anchor 600 cancomprise a housing 602 such as a tubular body, for coaxial movementalong the body 228. At the proximal end of the housing 602 can be aflange 666, such as an enlarged portion that is configured to contactthe surface of a bone. As will be explained in more detail below, incertain embodiments, the housing 602 may have diameter sized to fitthrough an opening formed in fixation bar or plate.

As will be explained below, the flange 666 can be configured to sitagainst the outer surface of a vertebra, a fixation plate, a fixationrod and/or a washer. The flange 666 is preferably an annular flange, tooptimize the footprint or contact surface area between the flange 666and the bone or other device. Circular or polygonal shaped flanges foruse in spinal fixation will generally have a diameter of at least about3 mm greater than the adjacent body 228 and often within the range offrom about 2 mm to about 30 mm or more greater than the adjacent body228.

With continued reference to FIGS. 2A-2D, the proximal end 230 of thebody 228 can be provided with a rotational coupling 270, for allowingthe second portion 238 of the body 228 to be rotationally coupled to arotation device. The proximal end 230 of the body 228 can be desirablyrotated to accomplish some discrete functions. In some embodiments, theproximal end 230 can be rotated to remove the second portion 238 of thebody 228 following tensioning of the device across a fracture or toanchor an attachment to the bone. Rotation of the rotational coupling270 can also be utilized to rotationally drive the distal anchor intothe bone. Any of a variety of rotation devices can be utilized, such aselectric drills or hand tools, which allow the clinician to manuallyrotate the proximal end 230 of the body. Thus, the rotational coupling270 can have any of a variety of cross sectional configurations, such asone or more flats or splines.

With particular reference to FIG. 2A, the fixation device can include anantirotation lock between the first portion 236 of the body 228 and theproximal anchor 600. In the illustrated embodiment, the first portion236 includes a pair of flat sides 280, which interact with correspondingflat structures 282 in the proximal anchor 600. One, three or moreaxially extending flats can also be used. As such, rotation of theproximal anchor 600 can be transmitted to the first portion 236 and thedistal anchor 234 of the body 228. Of course, those of skill in the artwill recognize various other types of splines or other interfitstructures can be used to prevent relative rotation of the proximalanchor and the first portion 236 of the body 228. For example, in someembodiments, the first portion 236 can include three flat sides, whichinteract with corresponding flat structures on the proximal anchor.

To rotate the proximal anchor 600, the flange 708 is preferably providedwith a gripping structure to permit an insertion tool to rotate theflange 708. Any of a variety of gripping structures can be provided,such as one or more slots, flats, bores or the like. In someembodiments, the flange 708 can be provided with a polygonal, and, inparticular, a pentagonal or hexagonal recess 284, as illustrated in FIG.5A.

Tensioning and release of the proximal anchor 600 can be accomplished ina variety of ways, depending upon the intended installation and removaltechnique. For example, a simple threaded relationship between theproximal anchor 600 and body 228 enables the proximal anchor 600 to berotationally tightened as well as removed. However, depending upon theaxial length of the threaded portion on the body 228, an undesirablylarge amount of time can be required to rotate the proximal anchor 600into place. For this purpose, the locking structures on the proximalanchor 600 can be adapted to elastically deform or otherwise permit theproximal anchor 600 to be distally advanced along the body 228 withoutrotation, during the tensioning step. The proximal anchor 600 can beremoved by rotation as has been discussed. In addition, any of a varietyof quick release and quick engagement structures can be utilized. Forexample, the threads or other retention structures surrounding the body228 can be interrupted by two or more opposing flats 280. Two or morecorresponding flats are provided on the interior of the housing 602. Byproper rotational alignment of the housing 602 with respect to the body228, the housing 602 can be easily distally advanced along the body 228and then locked to the body 228 such as by a 90° or other partialrotation of the housing 602 with respect to the body 228. Other rapidrelease and rapid engagement structures can also be devised.

In a final position, the distal end of the housing 602 preferablyextends distally past the junction 240 between the first portion 236 andthe second portion 238. As illustrated in FIGS. 3A and 3B, the housing602 can be provided with one or more surface structures 654, such as aradially inwardly projecting flange 656, for cooperating withcomplementary surface structures 258 on the first portion 236 of thebody 228. In the illustrated embodiment, the complimentary surfacestructures 258 comprise a series of annular ridges or grooves 260. Thesurface structures 654 and complementary surface structures 258 permitdistal axial travel of the proximal anchor 600 with respect to the body228, but resist proximal travel of the proximal anchor 600 with respectto the body 228.

For example, as best seen in FIG. 3A, the proximal end of the flange 656can be biased towards the longitudinal axis of the body 228. When theproximal anchor 600 is urged proximally with respect to the body 228,the flange 656 can engage the grooves or ridges 260 of the complementarysurface structures 258. This prevents proximal movement of the proximalanchor 600 with respect to the body 228. In contrast, as best seen inFIG. 3B, when the proximal anchor 600 is moved distally with respect tothe body 228, the flange 656 can bend outwardly away from the body 228and the ridges 260 so as to allow the proximal anchor 600 to movedistally. Of course, those of skill in the art will recognize that thereare a variety of other complementary surface structures, which permitone way ratchet like movement. For example, a plurality of annular ringsor helical threads, ramped ratchet structures and the like forcooperating with an opposing ramped structure or pawl can also be used.In some embodiments, opposing screw threads can be dimensioned tofunction as a ratchet.

Surface structures 258 can be spaced axially apart along the body 228,between a proximal limit and a distal limit. The axial distance betweenproximal limit and distal limit is related to the desired axial workingrange of the proximal anchor 600, and thus the range of functional sizesof the fixation device 212. The fixation device 212 of the exemplaryembodiment can provide compression between the distal anchor 234 and theproximal anchor 600 throughout a range of motion following the placementof the distal anchor in a vertebra. That is, the distal anchor 234 maybe positioned within the cancellous and/or distal cortical bone of avertebra, and the proximal anchor 600 may be distally advanced withrespect to the distal anchor 234 throughout a range to providecompression without needing to relocate the distal anchor 234 andwithout needing to initially locate the distal anchor 234 in a preciseposition with respect to the proximal side of the bone or anothervertebra. Providing a working range throughout which tensioning of theproximal anchor 600 is independent from setting of the distal anchor 234can allow a single device to be useful for a wide variety of spinalfixation procedures, as well as eliminate the need for accurate devicemeasurement. In addition, this arrangement can allow the clinician toadjust the compression force during the procedure without adjusting theposition of the distal anchor 234. In this manner, the clinician canfocus on positioning the distal anchor sufficiently within the vertebrato avoid or reduce the potential for distal migration out of thevertebra, which may damage the particularly delicate tissue, bloodvessels, nerves and/or spinal cord surrounding or within the spinalcolumn.

In many applications, the working range can be at least about 10% of theoverall length of the device, and may be as much as 20% or 50% or moreof the overall device length. In the context of a spinal application,working ranges of up to about 10 mm or more can be provided, sinceestimates within that range can normally be readily accomplished withinthe clinical setting. The embodiments disclosed herein can be scaled tohave a greater or a lesser working range, as will be apparent to thoseof skill in the art in view of the disclosure herein.

With particular reference to FIGS. 2 and 4, the fixation device mayinclude an antirotation feature between the first portion 236 of thebody 228 and the proximal anchor 600. In the illustrated embodiment, thefirst portion 236 includes a pair of flat sides 280, which interact withcorresponding flat structures 682 in the proximal anchor 600. One orthree or more axially extending flats may also be used. Rotation of theproximal anchor 600 can be transmitted to the first portion 236 anddistal anchor 234 of the body 228. Of course, those of skill in the artwill recognize various other types of splines or other interfitstructures can be used to prevent relative rotation of the proximalanchor and the first portion 236 of the body 228.

To rotate the proximal anchor 600, the flange 666 is preferably providedwith a gripping structure to permit an insertion tool to rotate theflange 666. Any of a variety of gripping structures may be provided,such as one or more slots, flats, bores or the like. In someembodiments, the flange 666 can be provided with a polygonal, and, inparticular, a pentagonal or hexagonal recess 684.

In a modified embodiment, the housing 602 of the proximal anchor 600 caninclude one or more barbs that extend radially outwardly from thetubular housing 602. Such barbs provide for self tightening after thedevice has been implanted in the patient as described in a co-pendingU.S. Pat. No. 6,908,465, issued Jun. 21, 2005, which is incorporated byreference in its entirety herein. The barbs may be radiallysymmetrically distributed about the longitudinal axis of the housing602. Each barb can be provided with a transverse engagement surface, foranchoring the proximal anchor 600 in the bone. The transverse engagementsurface may lie on a plane which is transverse to the longitudinal axisof the housing 602 or may be inclined with respect to the longitudinalaxis of the proximal anchor 600. In either arrangement, the transverseengagement surface generally faces the contacting surface of the flange.As such, the transverse engagement surface inhibits proximal movement ofthe proximal anchor with respect to the bone.

FIGS. 5A-5F illustrate another embodiment of a proximal anchor 700. Theproximal anchor 700 can include a tubular housing 702. In theillustrated embodiment, the tubular housing 702 is attached to, coupledto, or integrally formed (partially or wholly) with a secondary tubularhousing 704, which includes one or more anti-rotational features 706(e.g., flat sides) for engaging corresponding anti-rotational featuresformed on the first portion 236. A flange or collar 708 can be attached,coupled or integrally formed with the proximal end of the secondarytubular housing. The illustrated embodiment also advantageously includesvisual indicia 716 (e.g., marks, grooves, ridges etc.) on the tubularhousing 704 for indicating the depth of the proximal anchor 700 withinthe bone.

As illustrated in FIG. 5C, the tubular housing 702 can have bridges 710with teeth or flanges 712 that can be configured such that the proximalanchor 700 can be distally advanced and/or removed with rotation. Theteeth or grooves 112 can be configured to engage complementary surfacesstructures on the body 228 (see FIG. 2A). One or more slots or openings714 can be formed in the tubular housing 702. The proximal anchor 700can be pushed towards the distal end of the body 228 and the teeth 712can slide along the and over the complementary surface structures 258 onthe body 228. In the illustrated embodiment, the bridge 710 can flexslightly away from the body 228 to allow such movement. The number andshape of the openings 714 and bridges 710 can be varied depending of thedesired flexing of the bridges 710 when the proximal anchor 700 is moveddistally over the body and the desired retention force of the distalanchor 700 when appropriately tensioned. In some embodiments, the teethon the proximal anchor 700 and the grooves on the body 228 can beconfigured such that the proximal anchor 700 can be rotated or threadedonto the first portion 236 in the distal direction and/or so that thatthe proximal anchor 700 can be removed by rotation.

FIGS. 6A-6D illustrate another embodiment of a proximal anchor 800. Inthe illustrated embodiment, the proximal anchor 800 includes a recess839 configured to receive a split ring 434. As will be explained indetail below, the proximal anchor 800 can include an anti-rotationfeature to limit or prevent rotation of the ring 434 within the proximalanchor 800. In light of the disclosure herein, those of skill in the artwill recognize various different configurations for limiting therotation of the ring 434.

In the illustrated embodiment, the proximal anchor 800 has a tubularhousing 804 that can engage with a body 228 or a first portion 236 of abody 228 as described above. With reference to FIGS. 6B and 6D, thetubular housing 804 can comprise one or more anti-rotational features806 in the form of a plurality of flat sides that are configured to matecorresponding anti-rotational features 280 or flat sides of the body 228of the fixation device. As shown in FIG. 6D, in the illustratedembodiment, the body 228 can have three flat sides 280. Disposed betweenthe flat sides 280 are the portions of the body 228 which include thecomplementary locking structures such as threads or ratchet likestructures as described above. The complementary locking structures caninteract with the ring 434 as described above to resist proximalmovement of the anchor 800 under normal use conditions while permittingdistal movement of the anchor 800 over the body 228.

As mentioned above, the ring 434 can be positioned within the recess839. In the illustrated embodiment, the recess 839 and ring 434 arepositioned near to and proximal of the anti-rotational features 806.However, the ring 434 can be located at any suitable position along thetubular housing 804 such that the ring 434 can interact with theretention features of the body

During operation, the ring 434 can rotate to a position such that thegap 431 between the ends 433 a, 433 b of the ring 434 lies above thecomplementary retention structures on the body 228. When the ring 434 isin this position, there is a reduced contact area between the split ring434 and the complementary retention structures thereby reducing thelocking strength between the proximal anchor 800 and the body 228. Inthe illustrated embodiment, for example, the locking strength can bereduced by about ⅓ when the gap 431 is over the complementary retentionstructures between flat sides 280. As such, it is advantageous toposition the gap 431 on the flat sides 280 of the body 228 that do notinclude complementary retention structures.

To achieve this goal, the housing 804 can include a pair of tabs 812,814 that extend radially inward from the interior of the proximal anchor800, as illustrated in FIG. 6C. The tabs 812, 814 are configured tolimit or prevent rotational movement of the ring 434 relative to thehousing 804 of the anchor 800. In this manner, the gap 431 of the ring434 can be positioned over the flattened sides 280 of the body 228.

In the illustrated embodiment, the tabs 812, 814 have a generallyrectangular shape and have a generally uniform thickness. However, it iscontemplated that the tabs 812, 814 can be square, curved, or any othersuitable shape for engaging with the ring 434 as described herein.

In the illustrated embodiment, the tabs 812, 814 are formed by making anH-shaped cut 870 in the tubular housing 800 and bending the tabs 812,814 inwardly as shown in FIG. 6D. As illustrated in FIG. 6D, the tabs812, 814 (illustrated in phantom) are interposed between the edges 433a, 433 b of the ring 434. The edges 433 a, 433 b of the ring 434 cancontact the tabs to limit the rotational movement of the ring 434. Thoseskilled in the art will recognize that there are many suitable mannersfor forming the tabs 812, 814. In addition, in other embodiments, thetabs 812, 814 can be replaced by a one or more elements or protrusionsattached to or formed on the interior of the proximal anchor 800.

FIGS. 7A-7B illustrate an embodiment of a fixation device 212 having aflange or washer 900. The washer 900 can be configured to interact withthe flange 666 of the proximal anchor 600 of any of the embodimentsdescribed herein. The washer 900 can include a base 902 and a side wall904. The base 902 and side wall 904 can define a curved, semi-sphericalor radiused surface 908 that interacts with the corresponding curved,semi-spherical or radiused surface 608 of the flange 666. The surface908 can surround an aperture 906 formed in the base 902. Thisarrangement can allow the housing 702 and/or body 228 to extend throughthe washer 900 and pivot with respect to the washer 900.

With particular reference to FIG. 7C, in the illustrated embodiment, theaperture 906 is elongated with respect to a first direction dl ascompared to a second direction d2, which is generally perpendicular tothe first direction d1. In this manner, the width w1 of the aperture inthe first direction is greater than the width w2 of the aperture in thesecond direction. The aperture 906 provides a channel 911 with a width wbetween the sides 911 a, 911 b defined with respect to the seconddirection d2 that is preferably greater than the maximum width of thetubular housing 602 but smaller than the width of the flange 666 suchthat the proximal anchor 600 can not be pulled through the aperture 906.The height h of the channel is defined between the sides 911 c, 911 d inthe second direction. As such, the elongated aperture 906 permitsgreater angular movement in a plane containing the first direction dl asportions of the proximal anchor 600 are allowed rotate into theelongated portions of the aperture 906. The aperture 906 can beelliptical or formed into other shapes, such as, for example, arectangle or a combination of straight and curved sides.

In some embodiments, the washer 900 can include a portion that isconfigured so that the proximal end 610 of the anchor 600 is retained,preferably permanently retained, within the washer 900. In theillustrated embodiment, the side walls 904 are provided with lips 910.The lips 910 can extend inwardly from the side walls 904 towards theaperture 906 and interact with the proximal end 610 of the flange 666 sothat the proximal anchor 600 is retained within the washer 900.Preferably, the washer 900 is toleranced to allow the proximal anchor600 to freely rotate with respect to the washer 900. In this manner, thewasher 900 and the proximal anchor 600 can move together for convenienttransport.

As described above, when the body 228, the proximal anchor 600 and thewasher 900 are deployed into a patient, the washer 900 can inhibitdistal movement of the body 228 while permitting at least limitedrotation between the body 228 and the washer 900. As such, theillustrated arrangement allows for rotational and angular movement ofthe washer 900 with respect to the body 228 to accommodate variableanatomical angles of the bone surface. This embodiment is particularlyadvantageous for spinal fixation and, in particular, trans-laminar,trans-facet and trans-facet-pedicle applications. In such applications,the washer 900 can seat directly against the outer surface of avertebra. Because the outer surface of the vertebra is typicallynon-planar and/or the angle of insertion is not perpendicular to theouter surface of the vertebra, a fixed flange can contact only a portionof the outer surface of the vertebra. This can cause the vertebra tocrack due to high stress concentrations. In contrast, the angularlyadjustable washer 900 can rotate with respect to the body and therebythe bone contacting surface can be positioned more closely to the outersurface. More bone contacting surface is thereby utilized and the stressis spread out over a larger area. In addition, the washer, which has alarger diameter than the body 228, or proximal anchor described herein,effectively increases the shaft to head diameter of the fixation device,thereby increasing the size of the loading surface and reducing stressconcentrations. Additionally, the washer 900 can be self aligning withthe outer surface of the vertebra, which can be curved or non-planer.The washer 900 can slide along the surface of the vertebra and freelyrotate about the body 228 until the washer 900 rests snugly against thesurface of the vertebra for an increased contact area between the boneand the washer 900. As such, the washer 900 can be conveniently alignedwith a curved surface of the vertebra.

In some embodiments, the washer 900 can have a surface treatment or boneengagement features that can engage with the surface of the bone toinhibit relative movement between the washer 900 and the bone. Thewasher 900 can include a plurality of bone engagement features in theform of one or more spikes (not shown) extending from the surface of thewasher 900. The spikes can contact the surface of the bone to provideadditional gripping support, especially when the flange 666 ispositioned against, for example, uneven bone surfaces and/or softtissue. Optionally, the washer 900 can have protuberances, roughenedsurface, ridges, serrations, or other surface treatment for providingfriction between the washer 900 and the surface of the bone. However, itshould be appreciated that in modified embodiments the washer 900 can beformed without the bone engagement features or surface treatments. As anindependent feature, for example, the washer 900 can be enlarged andincludes one or two or more openings for receiving one or set screws(not shown). The setscrews can be passed through the openings tosecurely fasten the washer 900 to a bone.

In some embodiments, the distal anchor 234 can have a helical structure270 for engaging cancellous bone, as illustrated in FIGS. 2A-2C. Thehelical structure 270, such as a flange, can either be wrapped around acentral core or an axial lumen, as discussed below. The flange canextend through at least one and generally from about two to about 250 ormore full revolutions depending upon the axial length of the distalanchor and intended application. For most fixation devices, the flangewill generally complete from about 2 to about 20 revolutions. Thehelical structure 270 is preferably provided with a pitch and an axialspacing to optimize the retention force within cancellous bone, tooptimize compression of the fracture. In some applications, it canadvantageous for the distal anchor to engage cortical bone. In suchapplications, the pitch and axial spacing can be optimized for corticalbone.

In the illustrated embodiment, the helical structure 270 is shapedgenerally like a flat blade or radially extended screw thread. However,it should be appreciated that the helical structure 270 can have any ofa variety of cross sectional shapes, such as rectangular, triangular orother as deemed desirable for a particular application through routineexperimentation in view of the disclosure herein. The outer edge of thehelical structure 270 defines an outer boundary. The ratio of thediameter of the outer boundary to the diameter of the central core canbe optimized with respect to the desired retention force within thecancellous bone and giving due consideration to the structural integrityand strength of the distal anchor 234. Another aspect of the distalanchor 234 that can be optimized is the shape of the outer boundary andthe central core, which in the illustrated embodiment are generallycylindrical with a tapered distal end 272.

The distal end 272 and/or the outer edges of the helical structure 270can be atraumatic (e.g., blunt or soft). This inhibits the tendency ofthe fixation device 212 to migrate anatomically distally further intothe bone after implantation. Distal migration is also inhibited by thedimensions and presence of the proximal anchor 700, which has a largerfootprint than conventional screws.

Referring to FIG. 8, a variation of the distal anchor 234 isillustrated. In the illustrated embodiment, the distal anchor has adouble helix structure. Each helix is spirally wrapped about animaginary cylinder through at least one and preferably from about 2 toabout 20 or more full revolutions per inch. In some embodiments, eachhelix can be wrapped around substantially cylindrical central core thatincludes a central lumen that also extends through the body. The helixstructure is preferably provided with pitch and an axial spacing tooptimize the retention force within cancellous bone, which optimizescompression. The distal end 272 of the helical structure 270 can bepointed or sharp. In some embodiments, the helix can be wrapped about 7revolutions per inch for an overall thread density of about 14revolutions per inch.

Sleeve

With reference to FIG. 9A, in some embodiments, the fixation device 212can include a sleeve 100. In the illustrated embodiment, the sleeve 100can be tubular and be configured to be disposed around a portion of thefixation device 212. The sleeve 100 can be made of a biocompatiblematerial and can help promote bone in-growth within a bone joint orfracture to help facilitate fusion of the bone segments. The sleeve 100can also improve integration of the fixation device 212 with the bone.In some embodiments, the sleeve 100 can be made of materials such asallograft (e.g., cortical bone, cancellous bone, demineralized bonematrix (DBM) or bone morphogenic protein (BMP)). In certain embodiments,the sleeve 100 can be made substantially or entirely of an allograft,such as cortical bone.

In some embodiments, the sleeve 100 can be made entirely of allograftbone (e.g., cortical bone, cancellous bone and/or a combination ofcortical and cancellous bone allograft). As will be described below, theuse of allograft bone can beneficially promote fusion across a jointand/or a facture. However, as will be described in more detail below,other materials, or bioabsorbable or biocompatible materials can beutilized, depending upon the dimensions and desired features in otherembodiments. For example, in one embodiment, the sleeve 100 issubstantially made entirely of allograft bone such that over 95% of theweight of the sleeve 100 is from allograft bone, in another embodiment,over 90% of the weight of the sleeve 100 is from allograft bone and inanother embodiment over 75% of the weight of the sleeve 100 is fromallograft bone. In some embodiments, the sleeve 100 can be formed ofallograft bone and certain portions can be formed or coated with anotherbiocompatible or bioabsorbable material, such as, a metal (e.g.,titanium), ceramics, nylon, Teflon, polymers, etc. In other embodiments,a portion of the sleeve 100 is formed from allograft bone while theremaining portions are made of another material metal (e.g., titanium),ceramics, nylon, Teflon, polymers. For example, portions of the sleeve100 that are intended to contact the area of fusion or the facture canbe formed of allograft bone with the remaining portions formed ofanother material (e.g., metal, ceramic, nylon, polymer etc.)

As discussed above, the sleeve 100 can help promote bone in growthand/or fusion across a bone joint and/or fracture. The sleeve 100 can bemade of a material that promotes bone in-growth and can have featuresthat also help in bone in-growth and fusion. As illustrated in FIGS.9B-9E, the sleeve 100 can have surface features that help promote bonein-growth. The sleeve 100 can have surface features such as textures,grooves, knurling, etc. For example, FIG. 9B illustrates a sleeve 100′with longitudinal channels and circumferential grooves. FIG. 9Cillustrates a sleeve 100″ with dimples. In a modified embodiment, bumpsor a combination of bumps and dimples could be provided. FIG. 9Dillustrates a sleeve 100′″ with diamond-pattern knurling. FIG. 9Eillustrates a sleeve 100″″ with longitudinal channels. In otherembodiments, the sleeve 100 can be generally smooth. The sleeve 100embodiments with some type of textured surface can improveosseoconduction between and along the sleeve 100 and the bone.

In some embodiments, the sleeve 100 can include other characteristicsthat help promote bone fusion, such as coatings, surface treatments,etc. For example, a plasma spray type of texture can be applied to thesleeve 100, which can be made of various materials, such as titaniumpolymers, BMP, etc.

In the embodiment illustrated in FIG. 9A, the sleeve 100 is disposedaround the housing 602 of the proximal anchor 600. In other embodiments,the sleeve 100 can be disposed around the body 228 instead of, or inaddition to the proximal anchor 600. Preferably, however, the sleeve 100does not extend over the distal anchor 234 and/or distal end 232 of thefixation device 212. In some embodiments, the sleeve 100 can have aclearance or loose fit with the fixation device 212. The sleeve 100 canbe assembled with the fixation device 212 just prior to being implanted.In some embodiments, the sleeve 100 can be held in place around thefixation device 212 by a friction fit. The tight fit or interference fitof the sleeve 100 over the fixation device 212 can advantageously helpwith osseointegration of the sleeve 100 and the fixation device 212 withthe native bone, since smaller gaps help bone growth. In someembodiments, a retention material, such as adhesives can be used to holdthe sleeve 100 in place on the fixation device 212. In otherembodiments, the sleeve 100 can have a mating feature that couples witha complementary mating feature on the fixation device 212, such ashooks, splines, tabs, channels and grooves, or any other mating featuresas would be known in the art.

As illustrated in FIGS. 10A-10B, in some embodiments, the sleeve 100 canhave a gap 102 extending along the longitudinal length of the sleeve100. The gap 102 can allow the surgeon to spread the sleeve 100 open toplace around the fixation device 212 from a lateral direction (i.e.,from the side of the device). In other embodiments, the gap 102 canallow the device to be expanded such that it can be fit over theproximal or distal end of the device along the longitudinal axis. Suchembodiments of the sleeve 100 can advantageously allow the placement ofthe sleeve 100 on the fixation device 212 after the fixation device 212has already been partially implanted and/or immediately prior toimplantation. For example, in one arrangement, the sleeve 100 can beprepped by a surgeon or technician and then applied to the device beforethe device is inserted into the patient and/or after a portion of thedevice has been inserted into the patient. In some embodiments, thesleeve 100 can have an inner diameter that is generally equal to orslightly smaller than the outer diameter of the body 228 of the fixationdevice 212, such that when the sleeve 100 is placed over the fixationdevice 212, the sleeve 100 can provide a compression force to form atight fit around the body 228 of the fixation device 212. The tight fitcan help promote bone in-growth inside a bone joint or fracture to helpfacilitate fusion of the bone segments and also promote osseoconduction,as mentioned above.

With reference to FIG. 11, in some embodiments, the sleeve 100 can be asheet 104 that can be wrapped around the fixation device 212. Forexample, a sheet of bone morphogenic protein (BMP) sponge can be wrappedaround the fixation device 212 to help the fixation device integratewith the native bone. In other embodiments, the sheet can be made ofother osseoconductive material, such as flexible allograft.

Although the sleeve 100 has been discussed with reference to aparticular fixation device, the sleeve 100 can be used with a pluralityof different types of fixation devices, such as regular screws and lagscrews. For example, FIG. 11 illustrates the BMP sponge disposed arounda portion of a regular fixation screw. In addition, the sleeve 100 canbe used in fixation of any part of the body, such as spinal fixation,femur fixation or any other bone fixation.

In embodiments using a sleeve 100, the hole drilled for implanting thefixation device 212 during the implant procedure can be drilled slightlylarger to accommodate the sleeve 100. This can be especially importantwhen using a flexible sheet of osseoconductive material to help preventthe sheet from bunching during the procedure. However, the hole shouldnot be drilled too large, otherwise the large gaps may hinderintegration between the sleeve 100 and the bone. Preferably, thediameter of the hole is 10% to 20% larger than the diameter of thesleeve 100 when positioned on the fixation device 212.

In some embodiments, the sleeve 100 can be coupled to the fixationdevice 212 before the fixation device 212 is implanted. For example, theproximal anchor 600 can be coupled with the body 228, and the sleeve 100can be coupled to the assembled fixation device 212 prior toimplantation. The entire assembly can then be implanted together intothe patient. In other embodiments, the fixation device 212 can bepartially implanted and the sleeve 100 can subsequently be attached. Forexample, the distal anchor 234 can be implanted into the bone. Thesleeve 100 can be attached to the proximal anchor 600 and then theproximal anchor 600 can be compressed onto the body 228. In preferredembodiments, the sleeve 100 can be disposed over the fracture in thebone or the gap between two bones that are fixed together. For example,in trans-facet fixation, the sleeve 100 can be positioned so that itextends across the gap between the facets. The sleeve 100 can helppromote bone in-growth across the fracture or gap and help strengthenthe fixation. The collar 1000 can help induce bone growth within thefracture or gap and promote bone fusion. In other embodiments, thesleeve 100 is not positioned over the fracture or gap.

Spinal Fixation

FIG. 12 illustrates an embodiment of the fixation devices 12A, 12Bimplanted in the spine to provide stability. In this example, thefixation devices 12A, 12B are used as trans-facet screws. That is, thefixation devices extend through a facet of a first vertebra and into thefacet of a second, typically inferior, vertebrae. As in the illustratedembodiment, this procedure is typically (but not necessarily) preformedwith bilateral symmetry. Thus, even in the absence of a stabilizing bartying pedicle screws to adjacent vertebrae or to the sacrum, and in theabsence of translaminar screws that can extend through the spinousprocess, the fixation devices 12A, 12B can be used to stabilize twovertebrae, such as L3 and L4 to each other pending the healing of afusion. In some embodiments, the body 228 of fixation devices 12A, 12Bhas a length of approximately 10 mm-30 mm and the diameter of the bodyis approximately 3 mm-5.5 mm.

As discussed above, a sleeve 100 can be disposed over the fixationdevices 12A, 12B to help with bone in-growth within the bone joint tohelp facilitate fusion of the facets and can also improve integration ofthe fixation devices 12A, 12B with the bone. As illustrated in FIG. 12,the sleeves 100 can extend across the gap between the facets.

FIG. 13 illustrates a modified arrangement for spinal fixation in whichthe fixation devices 12A′, 12B′ are used as trans-laminar facet screws.As shown in FIG. 13, in this embodiment of use, the fixation deviceextends through the spinous process and facet of a first vertebra andinto the facet of a second, typically inferior, vertebra. As with theprevious embodiment, this procedure is typically (but not necessarily)preformed with bilateral symmetry. In some embodiments, the body offixation devices 12A′, 12B′ can have a length of approximately 50 mm-90mm and the diameter of the body can be approximately 4 mm-5.5 mm. FIG.13 illustrates a sleeve 100′ disposed over the fixation devices 12A′,12B′ to help with bone in-growth witin the bone joint to help facilitatefusion of the facets and also improve integration of the fixationdevices 12A′, 12B′ with the bone. In the illustrated embodiment, thesleeves 100′ extend across the gap between the facets. In someembodiments it can be useful to disrupt the facet joint prior toinsertion of the fixation device.

FIG. 14 illustrates another modified arrangement for spinal fixation inwhich the fixation device 12A″, 12B″ is used as a facet-pedical screw(e.g., as used in the Boucher technique). In such an embodiment, thefixation device extends through the facet of a first vertebra and intothe pedicle a second, typically inferior, vertebra. As with the previousembodiment, this procedure is typically (but not necessarily) preformedwith bilateral symmetry. In such embodiments, the body of the fixationdevices 12A″, 12B″ can be approximately 20-40 millimeters in length andapproximately 3.0-5.5 millimeters in diameter. FIG. 14 illustrates asleeve 100″ disposed over the fixation devices 12A″, 12B″ to help withbone in-growth with the bone joint to help facilitate fusion of thefacets and also improve integration of the fixation devices 12A″, 12B″with the bone. In the illustrated embodiment, the sleeves 100″ extendacross the gap between the facets.

In some embodiments, such as illustrated in FIGS. 12-14, the flange ofthe proximal anchor can be supported directly against the outer surfaceof a vertebra. Because the outer surface is typically non-planar and/orthe insertion angle of the fixation device is not perpendicular to theouter surface, an angularly fixed flange may contact only a portion ofthe outer surface. That is, the contact surface of the flange may notsit flush on the outer surface of the vertebra and may cause thevertebra to crack due to high stress concentrations. This can result inpoor fusion rates.

As such, in these applications, the angularly adjustable washers 900 ofthe embodiments described with reference to FIGS. 7A-7C are particularlyadvantageous because the washer 900 can adjust with respect to the bodyand thereby the bone contacting surface can be positioned more closelyto the outer surface of the vertebra. This can result in more bonecontacting surface being utilized and the stress supported by thefixation device is spread out over a larger area of the vertebra. Theseangularly adjustable washers can also be used with the spinal cages androds. In such embodiments, the angle of the body fixation device may notbe perpendicular to the contact surface of the fixation rod or plate. Insuch situations, the angularly adjustable washers can allow the washersto rotate and sit flush against the fixation rod and plate.

In some embodiments, it may be advantageous to drill a counter bore intothe first vertebra for receiving a portion of the proximal anchor. Thecounter bore can have a diameter that is slightly larger than the outerdiameter of the proximal anchor so that the proximal anchor may sit atleast partially below the outer surface of the vertebra.

In certain regions of the spine, the dimension transverse to a facetjoint and through the adjacent facets is relatively small. In thesecircumstances, the fixation may desirably include a through bore,opening through the distal cortex of the distal facet. The fixationdevice described above can be utilized either in a blind holeapplication, which the distal anchor is buried within the bone, or athrough bore application is which the distal helix extends into andpotentially through the distal cortex.

Fractures

FIG. 15 illustrates another embodiment of a fixation device 212extending through the medial malleolus 326, across a medial malleolarfracture 330, and into the tibia 322. Although FIG. 15 illustratesfixation of both a lateral malleolar fracture 328 and medial malleolarfracture 330, either fracture can occur without the other as is wellunderstood in the art. Installation of the fixation devices acrossmalleolar fractures is accomplished utilizing the same basic stepsdiscussed above in connection with the fixation of femoral neckfractures.

Similar to as discussed above, a sleeve 100 can be disposed over thefixation devices 212 to help with bone in-growth in the bone fracture tohelp facilitate fusion of the bone segments and also improve integrationof the fixation devices 212 with the bone. As illustrated in FIG. 15,the sleeves 100 can extend across the fracture in the bones.

Femur

Referring to FIG. 16, there is illustrated a posterior side elevationalview of the proximal portion of a femur 510, having a fixation device512 positioned therein. Detailed descriptions of this and alternativefixation devices can be found in U.S. Pat. No. 6,511,481 issued on Jan.28, 2003 entitled METHOD AND APPARATUS FOR FIXATION OF PROXIMAL FEMORALFRACTURE, U.S. Pat. No. 6,908,465 issued on Jun. 21, 2005 entitledDISTAL BONE ANCHORS FOR BONE FIXATION WITH SECONDARY COMPRESSION andU.S. Pat. No. 6,890,333 issued on May 10, 2005 entitled METHOD ANDAPPARATUS FOR BONE FIXATION WITH SECONDARY COMPRESSION, which are herebyincorporated by reference herein. Although this embodiment of a fixationdevice 512 is disclosed in the context of fractures of the proximalfemur, as with the embodiments described above, the methods andstructures disclosed herein are intended for application in any of awide variety of bones and fractures, as will be apparent to those ofskill in the art in view of the disclosure herein.

The proximal end of the femur 510 comprises a head 514 connected by wayof a neck 516 to the long body or shaft 517 of the femur 510. Asillustrated in FIG. 16, the neck 516 is smaller in diameter than thehead 514. The neck 516 and head 514 lie on an axis which, on average inhumans, crosses the longitudinal axis of the body 517 of the femur 510at an angle of about 126°. The risk of fracture at the neck 516 iselevated, among other things, by the angular departure of the neck 516from the longitudinal axis of the body 517 of femur 510 and also thereduced diameter of the neck 516 with respect to the head 514.

The greater trochanter 518 extends outwardly above the junction of theneck 16 and the body 517 of the femur 510. On the medial side of thegreater trochanter 518 is the trochanteric fossa 520. This depressionaccommodates the insertion of the obturator externus muscle. The lessertrochanter 521 is located posteromedially at the junction of the neck516 and the body 517 of the femur 510. Both the greater trochanter 518and the lesser trochanter 521 serve for the attachment of muscles. Onthe posterior surface of the femur 510 at about the same axial level asthe lesser trochanter 521 is the gluteal tuberosity 522, for theinsertion of the gluteus maximus muscle. Additional details of the femurare well understood in the art and not discussed in further detailherein.

FIG. 16 illustrates a fracture 524 which crosses the femur approximatelyin the area of the greater trochanter 518. Fractures of the proximalportion of the femur 510 are generally classified as capital orsubcapital fractures, femoral neck fractures, intertrochantericfractures and subtrochanteric fractures. All of these fractures will bedeemed femoral neck fractures for the purpose of describing the currentembodiment.

Referring to FIG. 16, the fixation device 512 can include a body 528extending between a proximal end 530 and a distal end 532. The length,diameter and construction materials of the body 528 can be varied,depending upon the intended clinical application. In embodimentsoptimized for various fractures in an adult human population, the body528 will generally be within the range of from about 10 mm to about 150mm in length after sizing, and within the range of from about 2 mm toabout 8 mm in maximum diameter. The major diameter of the helicalanchor, discussed below, may be within the range of from about 2.7 mm toabout 12 mm. In general, the appropriate dimensions of the body 528 willvary, depending upon the specific fracture. In rough terms, for amalleolar fracture, shaft diameters in the range of from about 3 mm toabout 4.5 mm may be used, and lengths within the range of from about 25mm to about 70 mm. For condylar fractures, shaft diameters within therange of from about 3.5 mm to about 6.5 mm may be used with lengthswithin the range of from about 25 mm to about 70 mm. For collesfractures (distal radius and ulna), diameters within the range of fromabout 2.0 mm to about 4.5 mm may be used with any of a variety oflengths within the range of from about 6 mm to about 70 mm.

In some embodiments, the body 528 can be at least partially made oftitanium. However, as will be described in more detail below, othermetals or bioabsorbable or nonabsorbable polymeric materials may beutilized, depending upon the dimensions and desired structural integrityof the finished fixation device 512.

The distal end 532 of the body 528 can be provided with a cancellousbone anchor or distal cortical bone anchor 534. Additional details ofthe distal bone anchor are described below and in U.S. Pat. No.6,908,465 issued on Jun. 21, 2005 entitled DISTAL BONE ANCHORS FOR BONEFIXATION WITH SECONDARY COMPRESSION, which was incorporated by referenceabove. In general, in a femoral neck application, distal bone anchor 534is adapted to be rotationally inserted into the cancellous bone withinthe head 514 of the femur 510, to retain the fixation device 512 withinthe femoral head.

The proximal end 530 of the fixation device 512 is provided with aproximal anchor 600. Proximal anchor 600 is axially distally moveablealong the body 528, to permit compression of the fracture 524 as will beapparent from FIG. 16 and the description below. As will be explainedbelow, complimentary locking structures such as threads or ratchet likestructures between the proximal anchor 600 and the body 528 resistproximal movement of the anchor 600 with respect to the body 528 undernormal use conditions. The proximal anchor 600 preferably can be axiallyadvanced along the body 528 without rotation as will be apparent fromthe disclosure herein.

In the illustrated embodiment, proximal anchor 600 comprises a housingsuch as a tubular body, for coaxial movement along the body 528. As bestseen in FIG. 16, in a final position, the housing extends distally pasta junction between a first portion 536 and a second portion 538, similarto as discussed above in other embodiments. The proximal anchor 600 canhave one or more surface structures for cooperating with complementarysurface structures on the first portion 536 of the body 528, such asdiscussed above. In some embodiments, as discussed above, the proximalanchor 600 can include a washer that seats against the outer surface ofthe femur or tissue adjacent the femur.

As discussed above, a sleeve 100 can be disposed over the fixationdevice 512 to help with integration of the fixation device 512. Asillustrated in FIG. 16, the sleeve 100 can extend across the gap betweenthe facets.

Method of use

In use, the clinician first identifies a patient having a fracture to betreated, such as a femoral neck fracture, which is fixable by aninternal fixation device. With continued reference to embodimentillustrated in FIG. 16, the clinician can access the proximal femur,reduce the fracture if necessary and select a bone drill and drills ahole 90 in accordance with conventional techniques. Frequently, the hole90 has a diameter within the range from about 3 mm to about 8 mm. Thisdiameter may be slightly larger than the diameter of the distal anchor34. The hole 90 preferably extends up to or slightly beyond the fracture24. In embodiments using a sleeve 100, the hole drilled for implantingthe fixation device 512 can be drilled slightly larger to accommodatethe sleeve 100. However, the hole should not be drilled too large,otherwise the large gaps may hinder integration between the sleeve 100and the bone. In one embodiment, the diameter of the hole is 10-20% thanthe diameter of the sleeve 100 when positioned on the fixation device512. In certain embodiments, the clinician can use a bone drill with acounter sink configured for providing a larger diameter recesses for thehousing 702 and/or the flange 244 of the proximal anchor 600.

A fixation device 512 having an axial length and outside diametersuitable for the hole 90 is selected. As discussed above, a sleeve 100can be coupled to the fixation device 512 before the fixation device 512is implanted. In other embodiments, the fixation device 512 can bepartially implanted before the sleeve 100 is attached. The distal end532 of the fixation device 512 can be advanced distally into the hole 90until the distal anchor 534 reaches the distal end of the hole 90. Theproximal anchor 600 can be carried by the fixation device 512 prior toadvancing the body 528 into the hole 90, or can be attached followingplacement of the body 528 within the hole 90. Once the body 528 andproximal anchor 600 are in place, the clinician can use any of a varietyof driving devices, such as electric drills or hand tools to rotate theproximal anchor 600 and thus cancellous bone anchor 534 into the head ofthe femur. In some embodiments, the fixation device is configured to beself-drilling or self tapping such that a hole does not have be formedbefore insertion into the bone.

Once the anchor 534 is in the desired location, proximal traction can beapplied to the proximal end 530 of body 528, such as by conventionalhemostats, pliers or a calibrated loading device, while distal force isapplied to the proximal anchor 600. In this manner, the proximal anchor600 can be advanced distally until the anchor 600 fits snugly againstthe outer surface of the bone or tissue adjacent the bone and thefracture 524 or space between bones can be completely reduced.Appropriate tensioning of the fixation device 512 can be accomplished bytactile feedback or through the use of a calibration device for applyinga predetermined load on the implantation device. An advantage of thestructure of the present embodiment is the ability to adjust compressionindependently of the setting of the distal anchor 534.

Following appropriate tensioning of the proximal anchor 600, the secondportion 538 of the body 528 is preferably detached from the firstportion 536 and removed. In the illustrated embodiment, this involvesrotating the second portion 538 with respect to the first portion viathe coupling, as explained above. Following removal of the secondportion 538 of each body 528, the access site can be closed and dressedin accordance with conventional wound closure techniques.

An advantage of certain embodiments of the fixation devices disclosedabove is that the proximal anchor can provide the device with a workingrange such that one device can accommodate varying distances between thedistal anchor and the proximal anchor. In certain applications, thisallows the technician to focus on the proper positioning of the distalanchor with the knowledge that the proximal anchor lies within theworking range of the device. With the distal anchor positioned at thedesired location, the proximal anchor can then be advanced along thebody to compress the fracture and/or provide stability between bones. Ina similar manner, the working range provides the technician withflexibility to adjust the depth of the proximal anchor. For example, insome circumstances, the bone can include voids, cysts osteoporotic bonethat impairs the stability of the distal anchor in the bone.Accordingly, in some circumstances, the technician can advance thedistal anchor and then desire to retract the distal anchor such that itis better positioned in the bone. In another circumstance, thetechnician can inadvertently advance the distal tip through the boneinto a joint space. In such circumstances, the working range of thedevice allows the technician to reverse and retract the anchor andrecompress connection. Such adjustments are facilitated by the workingrange of the proximal anchor on the body.

In one embodiment, the clinician will have access to an array offixation devices having, for example, different diameters, axial lengthsand angular relationships. These can be packaged one per package insterile envelopes or peelable pouches, or in dispensing cartridges whichcan each hold a plurality of devices. Upon encountering a fracture forwhich the use of a fixation device is deemed appropriate, the clinicianwill assess the dimensions and load requirements, and select a fixationdevice from the array which meets the desired specifications.

As noted above, in spinal fixation applications, the fixation device 12can be used as a trans-facet screw. That is, the fixation device extendsthrough a facet of a first vertebra and into the facet of a second,typically inferior, vertebrae. This procedure is typically (but notnecessarily) preformed with bilateral symmetry. Thus, even in theabsence of a stabilizing bar tying pedicle screws to adjacent vertebraeor to the sacrum, and in the absence of translaminar screws that canextend through the spinous process, the fixation devices can be used tostabilize two vertebrae, such as L3 and L4 to each other pending thehealing of a fusion. In some embodiments, the body 28 of fixation device12 can have a length of approximately 10 mm-30 mm and the diameter ofthe body is approximately 3 mm to 5.5 mm.

The fixation device 12 can also be used as a trans-laminar facet screw.In this embodiment of use, the fixation device can extend through thespinous process and facet of a first vertebra and into the facet of asecond, typically inferior, vertebra. As with the previous embodiment,this procedure is typically (but not necessarily) preformed withbilateral symmetry. In some embodiments, the body 28 of fixation device12 can have a length of approximately 50 mm-90 mm and the diameter ofthe body is approximately 4 mm to 5.5 mm.

The fixation device can also be used is used as a facet-pedical screw(e.g., as used in the Boucher technique). In such embodiments, thefixation device extends through the facet of a first vertebra and intothe pedicle a second, typically inferior, vertebra. As with the previousembodiment, this procedure is typically (but not necessarily) preformedwith bilateral symmetry. In such embodiments, the fixation device 12 andthe body 28 can be approximately 20-40 millimeters in length and 3.0-5.5millimeters in diameter.

The specific dimensions of any of the bone fixation devices describedherein can be readily varied depending upon the intended application, aswill be apparent to those of skill in the art in view of the disclosureherein. Moreover, although the present invention has been described interms of certain preferred embodiments, other embodiments of theinvention including variations in the number of parts, dimensions,configuration and materials will be apparent to those of skill in theart in view of the disclosure herein. In addition, all featuresdiscussed in connection with any one embodiment herein can be readilyadapted for use in other embodiments herein to form various combinationsand sub-combinations. The use of different terms or reference numeralsfor similar features in different embodiments does not imply differencesother than those which can be expressly set forth. Accordingly, thepresent invention is intended to be described solely by reference to theappended claims, and not limited to the preferred embodiments disclosedherein.

1. (canceled)
 2. A method of providing bone fixation, comprising the steps of: advancing a fixation device that comprises a body having a first portion that forms a bone anchor and a second portion that forms a proximal end into a first bone structure; securing the first bone structure to a second bone structure by advancing a proximal anchor against the second bone structure; and placing a sleeve formed substantially of allograft and carried by the fixation device across a bone joint or fracture site between the first bone structure and the second bone structure.
 3. The method of claim 2, further comprising moving the proximal anchor distally along the body of the fixation device.
 4. The method of claim 2, further comprising placing the sleeve over at least a portion of the fixation device.
 5. The method of claim 2, wherein adhesive is placed between the sleeve and fixation device.
 6. The method of claim 2, wherein the step of advancing the bone anchor of the fixation device into the first bone structure comprises rotating the bone anchor.
 7. The method of claim 2, where the first and second portion of the body of the fixation device is detachably coupled to each other at a junction.
 8. The method of claim 7, further comprising separating and removing the second portion from the first portion of the fixation device after the proximal anchor is advanced distally along the fixation device.
 9. The method of claim 2, further comprising forming a hole extending across the bone joint or fracture site between the first bone structure and the second bone structure; and advancing the sleeve formed substantially of bone allograft into the hole such that the sleeve spans the bone joint or fracture site between the first bone structure and the second bone structure.
 10. The method of claim 9, wherein advancing the sleeve into the hole comprises advancing the fixation device across the bone joint or fracture site between the first bone structure and the second bone structure.
 11. The method of claim 4, comprising placing the sleeve over at least a portion of the fixation device before the advancing step.
 12. The method of claim 4, comprising placing the sleeve over at least a portion of the fixation device after the fixation device has been at least partially advanced into the first bone structure.
 13. The method of claim 4, comprising disposing the sleeve around a housing of the proximal anchor.
 14. The method of claim 13, wherein the securing step comprises advancing a tubular body of the housing of the proximal anchor along the body of the fixation device.
 15. The method of claim 14, wherein the securing step comprises advancing the tubular body so as to engage a flange at a proximal end of the housing against the second bone structure.
 16. The method of claim 4, comprising disposing the sleeve around the body of the fixation device.
 17. The method of claim 16, comprising disposing the sleeve around the fixation device such that the sleeve does not extend over the distal anchor. 